Five key things to watch out for in the European Health Data Space proposal

Tomorrow, the Commission is scheduled to publish its long-awaited proposal for the European Health Data Space (EHDS).

It was really about time. Health is one of the sectors that generates the largest amount of data. We have long been advocating that we should put this data to good use.

It is literally a matter of life or death, when?over 4 million people?in Europe are diagnosed with cancer every year, a number expected to reach 5.2 million by 2040.

And failing to act is seriously hampering our potential to shape the health technologies best responding to our needs, condemning us to rely on life-saving products and technologies developed in regions where access to data and barriers to growth are not an issue.

The EHDS is a massively ambitious project, and it is crucial that we get it right from the start. There are a few points I’m looking forward to seeing in the final proposal, because they will make all the difference between a successful EHDS, and one that might actually end up worsening the already fragmented health landscape in Europe:

1. Is the EU really going to coordinate health?

Healthcare is a competence of Member States, we know. But COVID has somehow put this in perspective, with an overwhelming consensus for the EU to take a more central role in public health matters, supporting Member States. This is an important lesson from the pandemic that we must see reflected in the EHDS proposal: clearly reaffirming the EU’s coordinating role for the digital transformation of health systems.

2. Is the EHDS duplicating, or worse, contradicting other legislation on data governance?

In addition to the well-established GDPR, recently there has been an Act for everything data-related: the Data Governance Act, the Data Act, the AI Act. The EHDS itself will overlap with, and in certain cases build on, these requirements. There is a concrete risk that this will create more fragmentation and burdens in compliance, if we’re not crystal-clear on the scope and interaction between those Acts. Take for instance the current ambiguity in non-personal health data flows between the EU and third counties.

3. Will we have enough budget to build the EHDS?

Who will foot the bill? It’s a difficult question for both the Commission and the Member States. The EHDS is a massive endeavour and it needs proper resources. In 2022, the estimated budget for the EHDS under the EU4Health programme is between 80 and 100 million euros. If we consider that we’re trying to build a network allowing the secure use (and re-use) of health data from almost 500 million people, across 27 countries, we start to realise that way more resources are needed. So, the final text needs to clearly state how much money is needed and where it will come from.

4. Is the EHDS getting in the details of how it will work?

Proposing the EHDS is one thing, but implementing it consistently across Member States is a whole other story. We have already seen this with the GDPR. If the proposal lacks clarity on implementation, leaving it to a myriad of Delegated and Implementing Acts, it will be a definite red flag. The EHDS is trying to solve fragmentation, and any ambiguity in the final text would be a step further away from the goal.

5.?Is the EHDS a top-down exercise, or does it involve everyone in its governance?

The EHDS should above all lead to better health for people. Secondly, it needs to be an actionable framework for those who will be using these insights to advance research and develop new drugs, devices and services: researchers, technology and health companies. It’s crucial that everyone who has a stake in this – patient associations, healthcare professionals, researchers, industry – are involved in the shaping of the EHDS by participating in its governing board, or there will never be the trust needed.